Study to evaluate the efficacy and safety of supportive mitomycin C administered via electric current in the treatment of non-muscle invasive bladder cancer versus the standard immunotherapy.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Presurgy S.L.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

15 Dec 2021 → ongoing

Decision date (initial)

2025-01-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

ARQUER DIAGNOSTICS · PHYSION, SRL · PRESURGY S.L.

External identifiers

EU CT number

2024-520006-19-00

EudraCT number

2018-004273-27

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Therapy, Efficacy

To evaluate the efficacy of the adjuvant with EMDA-MMC (induction x6 weekly instillations and 1 year of maintenance) compared with the BCG standard (induction x6 weekly instillations and 1 year of maintenance) in the adjuvant treatment of High Grade NMLCC.

Secondary objectives 2

1. To assess the tolerance to adjuvant endovesical chemotherapy with EMDA-MMC compared to the BCG standard (induction x6 weekly instillations and 1 year of maintenance) in the adjuvant treatment of high-grade NMIBC.
2. To assess the impact on quality of life of adjuvant endovesical chemotherapy with EMDA-MMC compared to the BCG standard (induction x6 weekly instillations and 1 year of maintenance) in the adjuvanttreatment of high-grade NMIBC.

Conditions and MedDRA coding

Non-muscle invasive bladder cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patients older than 18 years and life expectancy ≥ 5 years.
2. Patients able to give informed consent for the study.
3. Patients with primary non-muscle infiltrating urothelial non-muscle metamorphosed (NMIBC), uni- or multi-focal, stages Ta and T1, High Grade (2004 WHO), including old G2 High Grade and all G3.
4. Patients treated with optically complete TUR of the tumor and, when indicated by clinical guidelines, RE-RTU that must be performed within the first 6 weeks.
5. Negative bladder random biopsies for Tcis
6. Presence of own muscle in the TUR and / or in the RE-RTU.
7. RE-RTU in all cases of T1 and also in Ta tumors when the initial TUR is incomplete or with absence of muscle in the sample.

Exclusion criteria 13

1. Patients unable to give informed consent for their participation in the study.
2. Patients with a history of allergic reactions to BCG or MMC.
3. Patients with pacemakers or DICs
4. Previous history of bladder tumors.
5. Antecedents of pelvic radiotherapy (bladder, prostate, rectum, vagina, uterus).
6. Absence of own muscle in the sample (neither in RTU nor in RE-RTU).
7. Patients with stage T1 who have not received RE-RTU.
8. Patients with Tcis isolated or associated with papillary tumor.
9. Presence of squamous cell carcinoma of the bladder or bladder adenocarcinoma
10. Stage tumors ≥T2.
11. cN + and / or cM + tumors.
12. Pregnant women.
13. Relative contraindications for the use of the EMDA system - Urethral stricture. - Giant prostatic lobe with bladder neck occlusion. - Psychosis - Alcoholism - Active untreated urinary infection

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 5-year tumor recurrence rate. Defined as the percentage of pathologically confirmed urothelial carcinoma recurrences following transurethral resection (TUR) or biopsy, after a specified period of time during which the patient has remained disease-free. Recurrence rates will be compared between the two study groups.

Secondary endpoints 8

1. Disease-free survival (DFS).
2. Tumor progression rate, defined as the percentage of patients who develop stage ≥ T2 disease.
3. Tumor progression-free survival (PFS).
4. Overall survival.
5. Adjuvant treatment completion rate.
6. Cost-effectiveness evaluation of the use of the developed model for the follow-up of patients with high-grade NMIBC treated with adjuvant BCG or EMDA-MMC
7. Prospective and detailed recording of adverse events (AEs) and serious adverse events (SAEs).
8. Impact of adjuvant treatment on patient quality of life (FACT-BL, HADs, and Distress Thermometer).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Presurgy S.L.

Sponsor organisation

Presurgy S.L.

Address

Calle Pollensa 4 Oficinas 7 Y 8

City

Las Rozas De Madrid

Postcode

28290

Country

Spain

Scientific contact point

Organisation

Presurgy S.L.

Contact name

Carolina Alos Barco

Public contact point

Organisation

Presurgy S.L.

Contact name

Carolina Alos Barco

Third parties 1

Locations

1 EU/EEA country · 20 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications